By Roger Chriss, PNN Columnist
The legal status of cannabidiol (CBD) is changing. Once classified exclusively as a Schedule I drug under the Controlled Substances Act, CBD is now legal under federal law. And this means regulation.
The 2018 Farm Bill removed hemp from Schedule I. Hemp is a strain of marijuana with very low levels of THC, but high amounts of CBD. This has opened the door to a legal market for CBD products, including food and supplements. But there’s a catch. The FDA has strict regulations about CBD being used in dietary supplements or promoted as medical treatments.
“It’s unlawful under the FD&C Act (Federal Food, Drug, and Cosmetic Act) to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived,” FDA commissioner Scott Gottlieb, MD, said in a December 2018 statement.
“Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use.”
The FDA has a FAQ page about cannabis that answers some basic questions:
"Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements? A. No."
"Is it legal, in interstate commerce, to sell a food to which THC or CBD has been added? A. No."
The FDA has reason to be concerned. Product quality for CBD products is iffy at best. An investigation by the NBC affiliate in Miami (see “Patients Are Being Duped”) found that 20 of 35 CBD products tested had less than half the amount of CBD advertised on the label. Some samples had no CBD at all.
Other recent analyses have found THC, pesticides, synthetic cannabinoids and toxic solvents in CBD products.
Moreover, a lack of regulatory oversight has led to an abundance of false, misleading or unsubstantiated claims. A recent review of CBD in the Journal of Clinical Pharmacology found that “CBD has been touted for many ailments for which it has not been studied, and in those diseases with evaluable human data, it generally has weak or very weak evidence.”
There is a lot of research on CBD going back years. The FDA’s approval of the CBD-based drug Epidiolex for rare childhood seizure disorders and a 2018 review that found potential for treating multiple sclerosis symptoms are important indicators of CBD’s medical value. At the same time, researchers have found no benefit in treating spinal cord injury, Crohn’s disease and osteoarthritis.
Yet CBD is now being widely promoted as a wellness product, and added to everything from coffee and pastries to bath oils and mascara. So it is not surprising that the FDA is concerned that people may be duped or put at risk.
The FDA is not alone in this. The New York City Department of Health has banned CBD products from being sold in bars and restaurants. Maine, New York, and Ohio are also banning CBD edibles.
For medically complicated people with chronic illness, regulation could be beneficial. At present these patients face significant risks with CBD products. Tainted CBD may cause unexpected allergic reactions or drug interactions. And contaminated CBD could trigger a positive result on a urine drug test, a common part of pain management amid the opioid crisis. Regulatory oversight could help reduce these risks.
The legal and regulatory landscape surrounding CBD is shifting quickly. The FDA and state government agencies are watching closely and starting to intervene. This may flush out bad actors in the CBD marketplace and improve product quality and reliability. A stable marketplace with reliable products may be a net gain for the people who stand to benefit the most from CBD.
Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.
The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.